Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the ...
Learn about the when, why and how USP works with industry stakeholders and other pharmacopeias to develop the monographs within the USP-NF. Leaders in the industry take a very proactive approach in ...
Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...
The process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus ...
Wilmington, N.C., March 30, 2011 - AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw materials testing ...
The new <1226>, 'Verification of Compendial methods' was published in second supplement to USP 30 - NF 25 (2007) and is now official. Compliance to USP <1226> is one of the FDA requirements for ...
USP plans to release a new version of the Chapter 1226. This seminar will provide all information on existing and new USP and FDA requirements. Attendees will also receive strategies and tool kits ...
Natural cyclodextrins (CDs) and their synthetically modified derivatives, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are widely used in pharmaceuticals as ...
WILMINGTON, N.C., March 30, 2011 /PRNewswire/ -- AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw ...
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